As with last year, all-round psychedelic powerhouse Michael Haichin invited me to offer some thoughts on what I took to be the most important or interesting psychedelic research articles of 2024. I only had time to write two reviews this year. Check out the rest of the annotated bibliography here.
Palitsky, R., Kaplan, D. M., Perna, J., Bosshardt, Z., Maples-Keller, J. L., Levin-Aspenson, H. F., Zarrabi, A. J., Peacock, C., Mletzko, T., Rothbaum, B. O., Raison, C. L., Grant, G. H., & Dunlop, B. W. (2024). A framework for assessment of adverse events occurring in psychedelic-assisted therapies. Journal of psychopharmacology (Oxford, England), 38(8), 690–700. https://doi.org/10.1177/02698811241265756
The systematic assessment of adverse events (AEs) in P-AT remains an important challenge for researchers and clinicians. With psychedelics not yet licensed, regulators rightly demand robust information about adverse events as well as treatment efficacy. Yet there is considerable room for improvement on AE reporting in psychedelic trials: a systematic review and meta-analysis last year found that nearly half of psychedelic trials reported no AE data whatsoever, and only 23.5% of post-2005 trials reported systematic approaches for ascertaining AEs (Hinkle et al., 2024).
The typical definition of AE deployed in standard pharmaceutical trials is “any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.” While this definition is appropriate for conventional pharmacotherapy, it may not adequately capture the full spectrum of challenging outcomes that may follow P-AT. Scholars are increasingly recognising this gap and developing specialised tools to address it, with Palitsky and colleagues’ Psychedelic Assisted Therapy Adverse Events assessment protocol (PATAE) joining the Swiss Psychedelic Side Effect Inventory (SPSI, Calder & Hasler, 2024) among last year’s important contributions to this evolving conversation.
At the heart of PATAE is the recognition that P-AT’s distinctive characteristics —combining pharmacological effects, psychotherapeutic processes, and spiritual-existential dimensions— require tailored approaches to AE detection. The framework developed by Palitsky et al. acknowledges that not all adversities arising from P-AT are best understood as “medical” in nature. They propose 54 AEs to track across seven categories specifically relevant to P-AT—sociocultural, psychospiritual, interpersonal, behavioural, psychotherapy-related, affective/cognitive/metacognitive, and perceptual—outcomes that are broadly invisible to standard AE frameworks.
The paper from Palitsky et al. implicitly raises an important issue about the entire enterprise of AE assessment: the question of what constitutes an adverse event is not merely technical but normative. Much as we may strive to be objective in scientific research, our measurement systems inevitably encode judgments about which outcomes matter and which don’t. When we privilege certain types of outcomes (like “adverse drug reactions”) over others (like shifts in worldview, difficulties in integration, or newly-challenging relationship dynamics), we risk imposing a narrow conception of what constitutes therapeutic success that may not align with patients’ own priorities and concerns. Palitsky’s framework invites us to reconsider what forms of adversity merit attention in P-AT. This is not merely a methodological choice, but a value-laden one with real implications for patients and for the development of the field itself.
The ethical implications of this measurement gap extend beyond research methodology into the realm of informed consent and patient autonomy. From an ethical perspective, what matters for informed consent is not whether an outcome meets regulatory criteria for an AE, but whether knowledge of its possibility would materially affect a prospective patient’s decision-making. By prioritising patient narratives and subjective appraisals over clinician determinations of therapeutic value, PATAE represents an important step toward fulfilling our ethical duty to properly inform patients about outcomes that may be highly salient to them, regardless of whether those outcomes fit neatly into conventional AE categories.
While offering an ambitious and much-needed expansion of what counts as “adverse,” the framework’s comprehensiveness raises important practical questions about implementation. The tension between thorough detection and feasible assessment represents one more dilemma for the field. As Cheung et al. note in their commentary on this paper, any assessment framework must balance the twin imperatives of comprehensiveness and practicality. A protocol too burdensome may lead to poor compliance and incomplete data collection; one too sparse may miss crucial outcomes.
The challenge ahead lies in operationalising these expanded AE criteria in a way that enhances both research integrity and patient care, without compromising feasibility or clinical applicability. At stake is not just regulatory compliance, but our capacity to understand the true risk:benefit profile of P-AT, and to communicate that understanding accurately to those who might wish to experience it
Jacobs, E., Earp, B. D., Appelbaum, P. S., Bruce, L., Cassidy, K., Celidwen, Y., Cheung, K., Clancy, S. K., Devenot, N., Evans, J., Lynch, H. F., Friesen, P., Romeu, A. G., Gehani, N., Maloof, M., Marcus, O., Martin Moen, O., Mertens, M., Nayak, S. M., … Yaden, D. B. (2024). The Hopkins-Oxford Psychedelics Ethics (HOPE) Working Group Consensus Statement. The American Journal of Bioethics, 24(7), 6–12. https://doi.org/10.1080/15265161.2024.2342764
The HOPE Consensus Statement is an offering from a group of 32 stakeholders— Indigenous scholars, psychiatrists, ethicists, psychedelic scientists, anthropologists, philosophers, and harm reduction specialists—convened to develop a shared understanding of ethical practice with psychedelics. The need for developing an ethics of psychedelics is crucial given the field’s history of serious transgressions—including MK Ultra experiments, abuses of patients and prisoners, sexual boundary violations by guides, and appropriative practices toward Indigenous communities—transgressions that regrettably are not confined to the distant past.
At four pages, the statement is deliberately minimal, offering a common orientation rather than exhaustive guidance. Many complex issues, such as the ethics of therapeutic touch during psychedelic experiences, will require considerable collaborative work among patients, practitioners, and ethicists.
For me, it was particularly important that the statement recognise that psychedelic ethics extends beyond medical contexts. Though clinical applications dominate headlines, the majority of psychedelic use always has, and always will, occur outside medical settings, including for spiritual, self-development, and recreational purposes. Such use is just as worthy of care and thoughtful attention, and we need ethical frameworks that look beyond the clinical, acknowledging the broader societal currents that psychedelic use is situated in.
The HOPE statement represents only a beginning in the conveners’ intention to better establish psychedelic ethics as a field of inquiry. Ethics is a conversation everyone has a stake in, not something to be agreed by 32 people. That’s why we were pleased to host an August summit for 200 people in Washington, D.C., expanding the conversation to include more diverse voices. But neither is ethics the preserve of academic and clinical circles, which is why we’ve made efforts to make the statement accessible—translating it into six languages to reach beyond traditional spheres of influence
Psychedelic Ethics 